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  1. Identify federal legislation that control drug use and abuse.
    Pure Food and Drug Act of 1906: set standards for drug labeling (everything had to be true); declare on label any identified dangerous or addicting substances (did not state if effective or safe); set standards for purity, potency, bioavailability, efficacy, and safety

    Food, Drug, and Cosmetic Act of 1938: replaced the 1906 act; added the requirement of safety testing of drugs before marketing

    Durham-Humphery Admendment 1952: distinguishes drugs that need or don't need a new prescription with refills

    Kefauver-Harris Drug Amendment 1962: provisions for evaluation for testing method; tightened controlls on drug safety; establishement of effectiveness of new drugs

    Controlled Substance Act 1970: 1) promotion of education and information on preventino and treatment of drug dependency, 2) strenthening of enforcement authority, 3) establish treatment facilities, 4) schedules for controlled substances
  2. Differentiate among Schedule I, II, III, IV, and V medications.
    Schedule I: high abuse potential; no accepted medical use

    Schedule II: high abuse potential with medical use; written prescription only; no refills

    Schedule III: medically accepted; may cause dependence; low physical, high psychological; written/oral prescription; 5 refills

    Schedule IV: mild physical/psychological dependence; 5 refills

    Schedule V: limited potential for dependence; written prescription or OTC
  3. Describe the nursing responsibilites associated with the administrating of each schedule.
    1) Account for all controlled drugs

    2) Keep a special controlled-substance record for required information

    3) Countersign all discarded or wasted medication

    4) Ensure that documentation and drugs on hand match

    5) Keep all controlled drugs in a locked storage area

    6) Be certain that only authorized persons have access to the keys
  4. Discuss how new drugs are tested for safety.
    Phase I: small groups (20-100); 4-6 week trial; purpose: determine optimal dosage range and pharmacokinetics

    Phase II: clients with disease, sevearl 100's; purpose: effective for diesase?, monitor SE

    Phase III: large numbers (1000's), medical research centers; purpose: identify infrequent, rare adverse effects-double blind study; new drug application

    Stage IV: post marketing survey; ongoing review; other uses; refine dose; drug interactions
  5. Define orphan drugs.
    no company would "adopt"; not profitable to develop; market too small or patent protection expired

    Orphan Drug Act of 1983: research grants, protocol development by FDA, 7 year exclusive marketing rights (shortens approval process, because no one would want to develop the drug)
  6. Discuss the role of the nurse in drug testing.
    asking relevant questions about informed consent and risk to benefit ratio; awareness of initial indicators of change in the client; prediction of increased risk for adverse drug reactions; recruitment and assessment of study subjects; thorough understanding of protocol; validity and reliability of measurement instruments; ongoing teamwork; communication with health care providers
  7. Define informed consent.
    must be fully informed about all treatments to enable clients to make decisions about their health care; not coerced, alert; nurses teach about the medications
  8. Identify ways to maintain confidentiality in drug administration.
    respect privileged information; need to know; don't talk in public; don't discuss medications in front of others; always ID the client first
  9. Purpose of medications.
    1) Diagnosis of disease

    2) Treatment of disease

    3) Cure disease

    4) Relief of symptoms

    5) Prevention of disease
  10. Drug Names.
    Chemical Name: drug's chemical compostition and molecular structure

    Generic Name: common name used by any manufacturer

    Official Name: chosen by FDA, often same as generic name

    Trade Name: brand name; regestered name given by manufacturer
  11. Units of measurment in metic system.
    Image Upload
  12. Metic to Household measurements.
    Image Upload
  13. Identify various routes for administering medications.
    IM, IV, Subcut, Oral
Card Set:
2012-06-11 18:09:35

exam 1
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